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This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) in the treatment of Moderate to Severe Plaque Psoriasis. The primary purpose is to assess the different maintaining treatment programme in Moderate to Severe plaque psoriasis by Qiangke®. And the second purpose is to assess the efficacy and safety of Qiangke® in Moderate to Severe Plaque Psoriasis. The trial will include 216 Moderate to Severe plaque psoriasis patients,and at the first stage they will be randomized divided into three group: full-dose of Qiangke® group, half-dose of Qiangke® group and placebo group.And the blind stage will last for 12 weeks. Then at the second stage, all patients will receive 50mg qw of Qiangke® for additional 12 weeks.
Psoriasis is a chronic inflammatory skin disease that can lead to significant physical and psychologic distress for patients.Recombinant Human TNF Receptor-Ig Fusion Protein for Injection (Qiangke®) can block the role of the cytokine tumor necrosis factor (TNF)-alpha.
TNF-α plays a major role in the pathophysiology of both Psoriasis(PsO)and Psoriatic Arthritis (PsA). TNF-α levels are elevated in psoriatic skin lesions, serum samples, and synovial fluid. Anti-TNF-α therapy has shown efficacy in treating psoriatic skin lesions, joint pain and swelling, enthesitis, and dactylitis plus the ability to improve mobility, reduce radiographic progression of disease, and influence quality of life parameters.
Qiangke® is a dimeric, soluble fusion protein consisting of the extracellular ligand binding portion of the TNF receptor linked to the Fc portion of human Immunoglobulin gamma-1(IgG1). It is capable of binding and neutralizing soluble TNF and transmembrane TNF. It alters neutrophil migration and dendritic cell and T-cell maturation and migration, thus decreasing the local and systemic production of pro-inflammatory cytokines and their subsequent effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etanercept | Experimental | Recombinant Human TNF Receptor-Ig Fusion Protein for Injection(Qiangke®) 50mg twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24 |
|
| etanercept (half dose) | Experimental | One vial of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection(Qiangke®) 25mg and one vial of placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week from Week 12 to Week 24 |
|
| Placebo | Placebo Comparator | Two vials of Placebo twice a week for 12 weeks, then Two vials of Recombinant Human TNF Receptor-Ig Fusion Protein for Injection(Qiangke®) 25mg twice a week from Week 12 to Week 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Biological | Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving PASI 90 & 50 | Week 12 | |
| Proportion of subjects achieving PASI 90 & 50 & 75 | Week 24 | |
| Physician's Global Assessment (PGA) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters - Number of Participants With Abnormal Laboratory Values and/or Adverse Events | Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment. | Week 12 & 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongzhong Jin, M.D. | Contact | 8613693583080 | jinhongzhong@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Hongzhong Jin, M.D. | Chinese Academy of Medical Sciences Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16081850 | Background | Gottlieb AB, Chamian F, Masud S, Cardinale I, Abello MV, Lowes MA, Chen F, Magliocco M, Krueger JG. TNF inhibition rapidly down-regulates multiple proinflammatory pathways in psoriasis plaques. J Immunol. 2005 Aug 15;175(4):2721-9. doi: 10.4049/jimmunol.175.4.2721. | |
| 18021890 | Background | Gudjonsson JE, Elder JT. Psoriasis: epidemiology. Clin Dermatol. 2007 Nov-Dec;25(6):535-46. doi: 10.1016/j.clindermatol.2007.08.007. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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|
|
| etanercept (half dose) | Biological | Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks. |
|
|
| placebo | Drug | two vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks. |
|
| Week 12 & 24 |
| Nail Psoriasis Severity Index (NAPSI) | Week 12 & 24 |
| Dermatology Life Quality Index (DLQI) | Week 12 & 24 |
| Patient's Global Assessment (PGA) | Week 12 & 24 |
| Institute of Dermatology and Skin Disease Hospital Chinese Academy of Medical Sciences | Recruiting | Nanjing | Jiangsu | 210042 | China |
|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
|
| Changhai Hospital of The Second Military Medical University | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| 9892952 | Background | Gupta MA, Gupta AK. Depression and suicidal ideation in dermatology patients with acne, alopecia areata, atopic dermatitis and psoriasis. Br J Dermatol. 1998 Nov;139(5):846-50. doi: 10.1046/j.1365-2133.1998.02511.x. |
| 14627786 | Result | Leonardi CL, Powers JL, Matheson RT, Goffe BS, Zitnik R, Wang A, Gottlieb AB; Etanercept Psoriasis Study Group. Etanercept as monotherapy in patients with psoriasis. N Engl J Med. 2003 Nov 20;349(21):2014-22. doi: 10.1056/NEJMoa030409. |
| 24790410 | Result | Kivelevitch D, Mansouri B, Menter A. Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis. Biologics. 2014 Apr 17;8:169-82. doi: 10.2147/BTT.S41481. eCollection 2014. |
| 15948997 | Result | Papp KA, Tyring S, Lahfa M, Prinz J, Griffiths CE, Nakanishi AM, Zitnik R, van de Kerkhof PC, Melvin L; Etanercept Psoriasis Study Group. A global phase III randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol. 2005 Jun;152(6):1304-12. doi: 10.1111/j.1365-2133.2005.06688.x. |
| 20124563 | Result | Sterry W, Ortonne JP, Kirkham B, Brocq O, Robertson D, Pedersen RD, Estojak J, Molta CT, Freundlich B. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. BMJ. 2010 Feb 2;340:c147. doi: 10.1136/bmj.c147. |
| 22348620 | Result | Chiu HY, Wang TS, Cho YT, Tsai TF. Etanercept use for psoriasis in Taiwan: a case series study. Int J Dermatol. 2013 Jun;52(6):673-80. doi: 10.1111/j.1365-4632.2011.05273.x. Epub 2012 Feb 20. |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |